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COMPANY ANNOUNCEMENT

Olympus Announces Voluntary Corrective Action for the Single-Use Ligating Device

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Medical Devices
Reason for Announcement:
Recall Reason Description
PolyLoop device may fail to detach as expected and become anchored to patient anatomy
Company Name:
Olympus Corporation
Brand Name:
Brand Name(s)
Olympus
Product Description:
Product Description
Single use ligating device

Company Announcement

“The firm updated the press on April 24, 2026 to inform customers of updates to their instructions for use to clarify correct handling and use.”

UPDATE: Olympus Corporation has announced an update to a medical device corrective action regarding its Single-Use Ligating Device (“PolyLoop”). Subsequent to the previous action, Olympus has updated the PolyLoop Instructions for Use (IFU) to clarify correct handling and loop-release techniques. The revised IFU includes previously issued guidance as well as supplemental explanations and illustrations intended to clarify the existing guidance. Users are asked to replace the previous IFU with the revised IFU and leaflet, “Preventing Incorrect and Incomplete Loop Detachment.”

Center Valley, Pa., (December 5, 2025)-Olympus Corporation today announced a voluntary medical device corrective action for its Single-Use Ligating Device ("Polyloop") following identification of a potential safety issue.

The Polyloop device is designed for use with Olympus endoscopes to deliver a nylon loop snare intended to prevent or control bleeding following polypectomy of pedunculated polyps.

Olympus took this action after receiving adverse event reports indicating that the Polyloop may fail to release or detach as expected during use, resulting in the loop becoming unintentionally anchored around patient anatomy. No deaths have been reported.

An unreleased ligation loop can present procedural challenges, requiring emergency intervention for removal from patient's anatomy. Risks include bleeding, mucosal injury, perforation, and in severe cases, the need for surgical intervention or hospitalization.

Customers were notified of the corrective action by letter in November 2025 and are asked to ensure all personnel are familiar with the supplemental illustrative guidance and existing warnings and cautions, including the emergency treatment procedure outlined in the Instructions for Use. Customers in the U.S. are asked to acknowledge receipt of the letter on the Olympus recall web portal by visiting: https://olympusamerica.com/recall and entering the recall number "0476".

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch program online: https://www.fda.gov/safety/medwatch­fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems­fda.

For information or to report a problem about the device, please contact the Olympus Technical Assistance Center at 1-800-848-9024, Option 1 or email complaints@olympus.com.

Company Contact Information

Consumers:
Olympus Technical Assistance Center
1-800-848-9024, Option 1
complaints@olympus.com
Media:
Susan Scerbo
(484) 505-0407
sue.scerbo@olympus.com
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